impression coping recall
impression coping, repositionable, short, screw-retained, PF 4.0
Why was impression coping recalled?
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
- Product
- impression coping, repositionable, short, screw-retained, PF 4.0
- Recalling firm
- Thommen Medical AG
- Quantity
- 20 units
- Distribution
- US Nationwide distribution in the states of OH and KY.
- Recall date
- March 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)